Sangji Kyleum Subsidiary Ace Biomed Receives MFDS Export Approval for COVID-19 Diagnostic Kit

[Asia Economy Reporter Jang Hyowon] Ace Biomed, a subsidiary of Sangji Kyleum, announced on the 16th that it has obtained export approval from the Ministry of Food and Drug Safety for its ultra-fast molecular diagnostic kit for COVID-19.

The COVID-19 diagnostic kit for which Ace Biomed obtained export approval, the ‘Palm PCR™ 2019-nCoV Fast Real-time RT-PCR Kit,’ is a product developed through a collaborative research and development and production-sales linkage system with Aram Biosystem, a company in which Ace Biomed has invested.

This Real-time RT-PCR kit measures the amount of PCR amplification products generated by RT-PCR in real time through fluorescent detection, allowing results to be confirmed within 50 minutes. It is characterized by high sensitivity and specificity.

Moreover, when using the mobile RNA extraction equipment and amplification devices from Aram Biosystem, in which Ace Biomed has invested, testing can be completed within one hour at the testing site, making it suitable for rapid diagnosis in places such as airports, ports, and hospital emergency rooms.

The company stated, “The convenience of being portable with charging capability and the ability to conduct tests anytime and anywhere has received positive evaluations from overseas buyers, resulting in a flood of inquiries,” adding, “We believe it will be competitive compared to diagnostic kits and diagnostic equipment from rival companies.”

In particular, the company expects that conducting tests with this kit at departure areas before boarding aircraft or ships will complete the testing before boarding, contributing to international health while also driving company sales.

Ace Biomed owns a production plant equipped with a GMP facility capable of mass production to ensure product stability and efficient workforce management. Not only diagnostic kits from Aram Biosystem but also RNA extraction devices and reagents are fully prepared for overseas export.

A company representative said, “Currently, the transmissibility of the coronavirus has become six times stronger than before, and as infectivity has increased, the importance of rapid testing and mobile coronavirus diagnostic equipment has grown,” adding, “Since we have made extensive preparations including product readiness and securing orders, we expect the business to progress rapidly.”